Fiasp 100 units/ml solution for injection in vial

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Fiasp 100 units/ml solution for injection in vial

insulin aspart

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor, pharmacist or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

1. What Fiasp is and what it is used for
2. What you need to know before using Fiasp
3. How to use Fiasp
4. Possible side effects
5. How to store Fiasp
6. Contents of the pack and other information

1. What Fiasp is and what it is used for

Fiasp is an insulin administered at mealtimes that rapidly lowers blood sugar levels. Fiasp is an injectable solution of insulin aspart and is used to treat diabetes mellitus in adults, adolescents, and children from 1 year of age. Diabetes is a condition in which the body does not produce enough insulin to control blood sugar levels. Treatment with Fiasp helps prevent complications of diabetes.

Fiasp should be injected from 2 minutes before starting a meal, with the possibility of administration up to 20 minutes after beginning the meal.

This medicine reaches its maximum effect between 1 and 3 hours after injection, and its effect lasts between 3 and 5 hours.

This medicine should normally be used in combination with intermediate- or long-acting insulins.

Additionally, it can be used for continuous infusion via an insulin pump.

2. What you need to know before using Fiasp

Do not use Fiasp

• if you are allergic to insulin aspart or to any of the other components of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting to use Fiasp. It is important that you are aware of the following:

• Low blood sugar (hypoglycemia): if your blood sugar level is too low, follow the instructions for low blood sugar provided in section 4 “Possible side effects”. Compared to other insulins taken at mealtime, Fiasp begins to lower blood sugar more quickly. If you experience hypoglycemia, you may feel it sooner after an injection of Fiasp.
• High blood sugar (hyperglycemia): if your blood sugar level is too high, follow the instructions for high blood sugar provided in section 4 “Possible side effects”.
• Switching from other insulins: your doctor may need to advise you about your insulin dose.
• If you are combining your insulin treatment with pioglitazone (an oral antidiabetic medicine used to treat type 2 diabetes), speak to your doctor as soon as possible if you experience symptoms of heart failure such as unusual shortness of breath, rapid weight gain, or localized swelling due to fluid retention (edema).
• Eye disorders: a sudden improvement in blood sugar control may temporarily worsen diabetes-related eye problems such as diabetic retinopathy.
• Nerve damage pain: if your blood sugar level improves very rapidly, you may experience nerve-related pain, which is usually temporary.
• Swelling of joints: when you start using the medicine, your body may retain more fluid than normal, causing swelling of the ankles and other joints. This effect usually disappears quickly. Make sure you use the correct type of insulin; always check the insulin label before each injection to avoid accidental mix-ups between insulins.
• Treatment with insulin may cause your body to produce antibodies against insulin (substances that act against insulin). However, very rarely only, this may require a change in your insulin dose.

Certain conditions and activities can affect your insulin requirements. Consult your doctor:

• if you have kidney, liver, adrenal gland, pituitary gland, or thyroid gland problems.
• if you are doing more physical exercise than usual or wish to change your normal diet, as this may affect your blood sugar level.
• if you are ill, continue your insulin treatment and consult your doctor.
• if you are traveling abroad; traveling across different time zones may affect your insulin needs and injection times.

When using Fiasp, it is strongly recommended that you record the name and batch number of each container to maintain a record of the batches used.

Skin changes at the injection site

You should rotate your injection site to help prevent changes in fatty tissue, such as thickening of the skin, skin shrinkage, or lumps under the skin. Insulin may not work well if injected into a lumpy, shrunken, or thickened area (see section 3 “How to use Fiasp”). Inform your doctor if you notice any changes at the injection site. Inform your doctor if you are currently injecting into these affected areas before switching to a different site. Your doctor may advise you to monitor your blood sugar levels more closely and may adjust your insulin or the dose of your other antidiabetic medicines.

Children and adolescents

This medicine is not recommended for use in children under 1 year of age.

Other medicines and Fiasp

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. Some medicines affect your blood sugar level, which may mean that your insulin dose needs to be changed.

The main medicines that can affect your insulin treatment are listed below.

Your blood sugar level may decrease (hypoglycemia) if you take:

• other diabetes medicines (oral and injectable)

• sulfonamide antibiotics (used to treat infections)

  • anabolic steroids (such as testosterone)

• beta-blockers (used to treat high blood pressure or angina)

  • salicylates (used to relieve pain and reduce fever)
  • monoamine oxidase inhibitors (MAOIs) (used to treat depression)

• angiotensin-converting enzyme (ACE) inhibitors (to treat certain heart conditions or high blood pressure).

Your blood sugar level may increase (hyperglycemia) if you take:

• danazol (a medicine that affects ovulation)

• oral contraceptives (birth control pills)

• thyroid hormones (to treat thyroid gland problems)

• growth hormone (to treat growth hormone deficiency)

• glucocorticoids (such as “cortisone”, to treat inflammation)

• sympathomimetics (such as epinephrine (adrenaline), salbutamol, or terbutaline, to treat asthma)

• thiazides (to treat high blood pressure or if the body retains too much fluid (fluid retention)).

Octreotide and lanreotide, used to treat acromegaly, a rare disorder characterized by excessive production of growth hormone. These medicines may either increase or decrease your blood sugar level.

If you are in any of the situations above (or are unsure), consult your doctor or pharmacist.

Use of Fiasp with alcohol

Drinking alcohol may change your insulin needs, as it can either raise or lower your blood sugar level. Therefore, you should monitor your blood sugar level more frequently than usual.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine. This medicine can be used during pregnancy; however, your insulin dose may need to be adjusted during pregnancy and after childbirth. Your insulin requirement usually decreases during the first 3 months of pregnancy and increases during the remaining 6 months. Careful diabetes control is necessary during pregnancy. Preventing low blood sugar (hypoglycemia) is especially important for your baby’s health. After delivery, your insulin requirements will likely return to what they were before pregnancy.

There are no restrictions on the use of Fiasp during breastfeeding.

Driving and using machines

Low blood sugar can affect your ability to drive or operate tools or machinery. If you have low blood sugar, your concentration and reaction ability may be impaired. This could endanger your life or the lives of others. Ask your doctor whether you can drive if:

• you have frequent episodes of hypoglycemia
• you find it difficult to recognize the symptoms of hypoglycemia.

Important information about some of the components of Fiasp

This medicine contains less than 1 mmol of sodium (23 mg) per dose; essentially, it is “sodium-free”.

3. How to use Fiasp

Follow exactly the administration instructions for this medicine given by your doctor.

If you are unsure, consult your doctor or pharmacist again.

When to use Fiasp

Fiasp is an insulin that is administered at mealtime.

Adults: Fiasp should be injected just before (0 to 2 minutes) starting to eat, with the possibility of administering it up to 20 minutes after the start of the meal.

Children: Fiasp should be injected just before (0 to 2 minutes) starting to eat, with the possibility of administering it up to 20 minutes after the start of the meal in situations where it is uncertain when the child will eat. Consult your doctor about these situations.

This medicine reaches its maximum effect between 1 and 3 hours after injection, and the effect lasts between 3 and 5 hours.

Fiasp dosage

Dosage for type 1 and type 2 diabetes

Your doctor will decide together with you:

• how much Fiasp you need with each meal
• when to check your blood sugar level and whether you need a higher or lower dose.

If you wish to modify your usual diet, consult your doctor, pharmacist, or nurse beforehand, as a change in diet may alter your insulin requirement.

When using other medicines, ask your doctor whether your treatment needs adjustment.

Dosage adjustment for type 2 diabetes

The daily dose depends on your blood sugar level at mealtimes the previous day and the previous night.

• Before breakfast: the dose should be adjusted according to the blood sugar level before lunch the previous day.

• Before lunch: the dose should be adjusted according to the blood sugar level before dinner the previous day.

• Before dinner: the dose should be adjusted according to the blood sugar level the previous night.

Use in elderly patients (65 years of age or older)

This medicine can be used in elderly patients. Talk to your doctor about possible dose adjustments.

If you have kidney or liver problems

If you have kidney or liver problems, you may need to monitor your blood sugar level more frequently. Talk to your doctor about possible dose adjustments.

Injecting Fiasp

This medicine is injected under the skin (subcutaneous injection) or by continuous infusion pumps. A healthcare professional must explain all aspects related to pump administration.

Where to inject

• The best areas for injection are the front of the waist (abdomen) or the upper arm.
• Do not inject into a vein or muscle.
• Change the injection site daily within the injection area to reduce the risk of developing skin changes (see section 4).

Do not use Fiasp

• if the vial's protective cap is loose or missing. The vial has a plastic protective cap to ensure a secure container. If the vial is not in perfect condition at the time of use, return it to the supplier.
  • if the vial has not been stored correctly (see section 5 “Storage of Fiasp”).
  • if the insulin does not appear clear (e.g., cloudy) and colorless.

How to inject Fiasp

Before using Fiasp for the first time, your doctor or nurse will show you how to do it.

1. Check the name and concentration on the vial label to make sure it is Fiasp.
2. Remove the protective cap from the vial.
3. Always use a new needle and syringe for each injection to prevent contamination. Needles and syringes must not be shared.
4. Draw into the syringe an amount of air equal to the dose of insulin to be injected. Inject the air into the vial.
5. Turn the vial and syringe upside down and draw the correct dose of insulin into the syringe. Remove the needle from the vial. Expel air from the syringe and verify that the dose is correct.
6. Inject the insulin under the skin. Use the injection technique advised by your doctor or nurse.
7. Dispose of the needle after each injection.

Use in an infusion pump

If you wish to use Fiasp with an infusion pump, follow your doctor's instructions and recommendations. Before using Fiasp in the pump, you must receive detailed instructions and information on what to do in case of illness, high or low blood sugar levels, or pump system failure. Fiasp may be used from a vial in an infusion pump system for up to 6 days.

Filling the pump

• Fiasp must never be diluted or mixed with another insulin.

• Before inserting the needle, wash your hands and the skin area where the needle will be inserted with water and soap to prevent any infection at the infusion site.

• When filling a new reservoir, ensure there are no large air bubbles in the syringe or catheter.

  • The infusion set (catheter and needle) must be changed according to the instructions provided in the product information accompanying the infusion equipment.

To get the most benefit from insulin infusion and to detect possible insulin pump failure, it is recommended to measure blood sugar levels regularly.

What to do in case of pump failure

You must always have an alternative insulin delivery system available to inject insulin under the skin (e.g., an injection pen or syringes) in case the pump fails.

If you use more Fiasp than you should

If you use too much insulin, your blood sugar level may become very low (hypoglycemia); see section 4 “Low blood sugar level”.

If you forget to use Fiasp

If you forget to inject your insulin, your blood sugar level may become very high (hyperglycemia). See section 4 “High blood sugar level”.

Three simple steps that can help you avoid low or high blood sugar levels:

• Always carry spare syringes and a spare vial of Fiasp.

• Always carry something that indicates you are diabetic.

• Always carry sugary products with you. See section 4 “What to do if your blood sugar level is low”.

If you stop using Fiasp

Do not stop treatment with your insulin without consulting your doctor. Stopping insulin administration could lead to very high blood sugar levels (severe hyperglycemia) and ketoacidosis (a condition involving excessive acid in the blood, which can be life-threatening). See symptoms and recommendations in section 4 “High blood sugar level”.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Low blood sugar (hypoglycemia) is a very common adverse effect of insulin treatment (it may affect more than 1 in 10 people). It can be very serious. Severe low blood sugar can lead to loss of consciousness. Severe hypoglycemia may cause brain damage and can be life-threatening. If you have symptoms of low blood sugar, take action to raise your blood sugar level immediately. See the recommendations below under “Low blood sugar”.

If you experience a severe allergic reaction (including anaphylactic shock) to insulin or any of the components of Fiasp (the frequency of this is unknown), stop using this medicine and contact emergency medical services immediately.

Symptoms of a severe allergic reaction may include:

• local reactions (e.g., rash, redness, itching) spreading to other parts of the body
  • sudden feeling of illness with sweating
  • vomiting
  • difficulty breathing
  • palpitations or dizziness.

Allergic reactions such as widespread skin rash and facial swelling may occur. These are uncommon and may affect up to 1 in 100 people. Consult a doctor if symptoms worsen or if you do not see improvement within a few weeks.

Skin changes at the injection site: If you inject insulin in the same place repeatedly, fatty tissue may shrink (lipoatrophy) or become thicker (lipohypertrophy) (these are uncommon and may affect up to 1 in 100 people). Lumps under the skin may also occur due to the buildup of a protein called amyloid (cutaneous amyloidosis; frequency unknown). Insulin may not work well if injected into a lumpy, shrunken, or thickened area. Change your injection site regularly to help prevent these skin changes.

Other adverse effects include:

Common (may affect up to 1 in 10 people)

Reaction at the injection site: Localized reactions at the injection site may occur. Symptoms may include rash, redness, swelling, bruising, irritation, pain, and itching. These reactions usually resolve after a few days.

Skin reactions: Skin allergy signs such as eczema, rash, itching, hives, and dermatitis may occur.

General effects of insulin treatment including Fiasp

• Low blood sugar (hypoglycemia) (very common)

Low blood sugar levels may occur if you:

Drink alcohol, inject too much insulin, exercise more than usual, eat very little, or skip a meal.

Warning signs of low blood sugar, which may appear suddenly: Headache, difficulty speaking, palpitations, cold sweating, cold and pale skin, nausea, excessive hunger, trembling, nervousness or anxiety, unusual tiredness, weakness, drowsiness, confusion, difficulty concentrating, temporary changes in vision.

What to do if your blood sugar level is low

• If you are conscious, treat your low blood sugar immediately with 15–20 g of fast-acting carbohydrates: take glucose tablets or a sugary product such as fruit juice, candy, or biscuits (always carry glucose tablets or sugary products in case you need them).
• It is recommended to recheck your blood glucose levels after 15–20 minutes and treat again if your blood glucose levels are still below 4 mmol/l.
• Wait until hypoglycemia symptoms have disappeared or your blood sugar level has stabilized. Continue insulin treatment as usual.

What people close to you should do if you lose consciousness

Inform people you spend time with that you have diabetes. Let them know what the consequences of low blood sugar may be, including the risk of losing consciousness.

Tell them that if you become unconscious, they should:

• lay you on your side to prevent choking

• seek immediate medical assistance

• do not give you anything to eat or drink, as you could choke.

You may regain consciousness more quickly if someone who knows how to do so administers a glucagon injection.

• If glucagon is administered, you should take glucose or a sugary product as soon as you regain consciousness.
• If there is no response to glucagon treatment, you must be treated in a hospital.

If severe hypoglycemia is not treated, it may eventually cause brain damage, which may be temporary or permanent. It can even lead to death.

Talk to your doctor if:

• your blood sugar has dropped so low that you lost consciousness
• you have received a glucagon injection
• you have recently experienced several episodes of low blood sugar.

You may need to adjust the dose or frequency of your insulin injections, your diet, or your physical activity.

• High blood sugar (hyperglycemia)

High blood sugar levels may occur if you:

Eat more or exercise less than usual, drink alcohol, have an infection or fever, do not inject enough insulin, repeatedly inject less insulin than you need, forget to inject insulin, or stop insulin treatment.

Warning signs of high blood sugar, which usually appear gradually:

Reddening of the skin,

dry skin,

feeling drowsy or tired,

dry mouth,

fruity breath odor (acetone),

increased need to urinate,

thirst,

loss of appetite,

nausea or vomiting.

These may be symptoms of a serious condition called ketoacidosis. This is an accumulation of acid in the blood due to the body metabolizing fat instead of sugar. If untreated, it could lead to diabetic coma and even death.

What to do if your blood sugar level is high

• Check your blood sugar level.
• Administer a correction dose of insulin if you have been instructed how to do so.
• Check for ketones in your urine.
• If ketones are present, seek medical assistance immediately.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor, pharmacist, or nurse, even if it is an effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Fiasp

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the label and packaging following EXP. The expiry date is the last day of the month indicated.

Before first use:

Store in a refrigerator (between 2°C and 8°C). Do not freeze. Keep away from the freezer. Keep the vial in the outer packaging to protect it from light.

After opening or when carried as a spare: The vial may be carried with you and stored at room temperature (not above 30°C) or in the refrigerator (between 2°C and 8°C) for 4 weeks (including time in the pump reservoir). Always keep the vial in the outer packaging to protect it from light.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Fiasp

• The active substance is insulin aspart. 1 ml of solution contains 100 units of insulin aspart. Each vial contains 1,000 units of insulin aspart in 10 ml of solution.
• The other components are phenol, metacresol, glycerol, zinc acetate, disodium phosphate dihydrate, arginine hydrochloride, nicotinamide (vitamin B3), hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment) (see end of section 2 “Important information about some of the components of Fiasp”), and water for injections.

Appearance of Fiasp and contents of the pack

Fiasp is a clear, colourless, aqueous injectable solution presented in a vial.

Each vial contains 10 ml of solution.

Pack sizes of 1 or 5 vials, or a multiple pack of 5 (1 x 10 ml) vials. Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Novo Nordisk A/S,

Novo Allé,

DK-2880 Bagsværd, Denmark

Date of the most recent revision of this leaflet:

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.